Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Quick Turnaround Testing of Communication Effectiveness, 51995-51996 [2022-18265]
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Federal Register / Vol. 87, No. 163 / Wednesday, August 24, 2022 / Notices
51995
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity/21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
HDE Records—814.126(b)(2) ..............................................
62
1
62
2
124
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3.—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Activity/21 CFR section
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Notification of emergency use—814.124(a) ........................
22
1
22
1
22
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
increase of 360 total burden hours and
a corresponding increase of five total
annual responses. For efficiency of
Agency operations, we are consolidating
the related information activity and
account for burden associated with HDE
regulations currently approved in OMB
control number 0910–0661. As a result,
there is an increase in the total number
of burden hours for this information
collection.
Dated: August 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
[FR Doc. 2022–18271 Filed 8–23–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
[Docket No. FDA–2019–N–0430]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Generic Clearance
for Quick Turnaround Testing of
Communication Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by September
23, 2022.
jspears on DSK121TN23PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
21:37 Aug 23, 2022
Jkt 256001
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0876. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
Generic Clearance for Quick
Turnaround Testing of Communication
Effectiveness
OMB Control Number 0910–0876—
Extension
The FDA Food Safety Modernization
Act (FSMA) (Pub. L. 111–353) enables
FDA to better protect public health by
helping to ensure the safety and security
of the food supply. It enables FDA to
focus more on preventing food safety
problems rather than relying primarily
on reacting to problems after they occur.
FSMA recognizes the important role
consumers and stakeholders play in
ensuring the safety of the food supply,
which helps ensure that suppliers
produce food that meets U.S. safety
standards.
Occasionally, FDA will need to
communicate with consumers and other
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
stakeholders about immediate health
issues that could affect public health
and safety. This collection of
information allows the use of fast-track
methods of communication such as
quick turnaround surveys, focus groups,
and indepth interviews collected from
consumers and other stakeholders to
communicate FDA issues of immediate
and important public health
significance. We plan on using these
methods of communication to collect
vital public health and safety
information.
For example, these methods of
communication might be used when
there is a foodborne illness outbreak,
food recall, or other situation requiring
expedited FDA food, dietary
supplement, cosmetics, or animal food
or feed communications. So that FDA
may better protect the public health, the
Agency needs quick turnaround
information provided by this collection
of information to help ensure its
messaging has reached the target
audience, has been effective, and, if
needed, to update its communications
during these events.
Respondents to this collection of
information include a wide range of
consumers and other FDA stakeholders
such as producers and manufacturers of
FDA-regulated food and cosmetic
products, dietary supplements, and
animal food and feed. Participation will
be voluntary.
In the Federal Register of April 18,
2022 (87 FR 22906), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Although three comments
were received, they were not responsive
to the four collection of information
topics solicited.
We estimate the burden of this
collection of information as follows:
E:\FR\FM\24AUN1.SGM
24AUN1
51996
Federal Register / Vol. 87, No. 163 / Wednesday, August 24, 2022 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Survey type
Total annual
responses
Average burden per
response
Total hours
Indepth Interviews, Cognitive Interviews Screener
Indepth Interviews, Cognitive Interviews .................
Indepth Interviews Screener ....................................
Indepth Interviews ....................................................
Survey Cognitive Interviews Screener .....................
Survey Cognitive Interviews ....................................
Pretest Survey Screener ..........................................
Pretest Survey .........................................................
Self-Administered Surveys—Study Screener ..........
Self-Administered Surveys .......................................
Focus Group/Small Group, Cognitive Groups
Screener.
Focus Group/Small Group, Cognitive Groups .........
Focus Group/Small Group Participant Screening ...
Focus Group/Small Group Discussion ....................
45
9
900
180
45
9
750
150
75,000
15,000
180
1
1
1
1
1
1
1
1
1
1
1
45
9
900
180
45
9
750
150
75,000
15,000
180
0.083 (5 minutes) ......
1 ................................
0.083 (5 minutes) ......
1 ................................
0.083 (5 minutes) ......
1 ................................
0.083 (5 minutes) ......
0.25 (15 minutes) ......
0.083 (5 minutes) ......
0.25 (15 minutes) ......
0.083 (5 minutes) ......
4
9
75
180
4
9
62
38
6,225
3,750
15
60
720
240
1
1
1
60
720
240
1.5 (90 minutes) ........
0.083 (5 minutes) ......
1.5 (90 minutes) ........
90
60
360
Total ..................................................................
........................
........................
........................
....................................
10,881
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: August 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–4188]
Tobacco Products: Principles for
Designing and Conducting Tobacco
Product Perception and Intention
Studies; Guidance for Industry;
Availability
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of a final guidance for
industry entitled ‘‘Tobacco Products:
Principles for Designing and Conducting
Tobacco Product Perception and
Intention Studies.’’ The final guidance
provides information intended to assist
applicants design and conduct tobacco
product perception and intention (TPPI)
studies that may be submitted as part of
a modified risk tobacco product
application (MRTPA), a premarket
tobacco product application (PMTA), or
a substantial equivalence (SE) report.
The final guidance discusses a variety of
scientific issues applicants may want to
SUMMARY:
VerDate Sep<11>2014
19:09 Aug 23, 2022
Jkt 256001
The announcement of the
guidance is published in the Federal
Register on August 24, 2022.
DATES:
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
BILLING CODE 4164–01–P
AGENCY:
consider as they design and conduct
TPPI studies.
ADDRESSES:
[FR Doc. 2022–18265 Filed 8–23–22; 8:45 am]
jspears on DSK121TN23PROD with NOTICES
Number of
responses per
respondent
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
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Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–D–4188 for ‘‘Tobacco Products:
Principles for Designing and Conducting
Tobacco Product Perception and
Intention Studies; Guidance for
Industry; Availability.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
E:\FR\FM\24AUN1.SGM
24AUN1
]]>Agencies
[Federal Register Volume 87, Number 163 (Wednesday, August 24, 2022)]
[Notices]
[Pages 51995-51996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18265]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0430]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Generic Clearance for
Quick Turnaround Testing of Communication Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by September 23, 2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0876. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Generic Clearance for Quick Turnaround Testing of Communication
Effectiveness
OMB Control Number 0910-0876--Extension
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353)
enables FDA to better protect public health by helping to ensure the
safety and security of the food supply. It enables FDA to focus more on
preventing food safety problems rather than relying primarily on
reacting to problems after they occur. FSMA recognizes the important
role consumers and stakeholders play in ensuring the safety of the food
supply, which helps ensure that suppliers produce food that meets U.S.
safety standards.
Occasionally, FDA will need to communicate with consumers and other
stakeholders about immediate health issues that could affect public
health and safety. This collection of information allows the use of
fast-track methods of communication such as quick turnaround surveys,
focus groups, and indepth interviews collected from consumers and other
stakeholders to communicate FDA issues of immediate and important
public health significance. We plan on using these methods of
communication to collect vital public health and safety information.
For example, these methods of communication might be used when
there is a foodborne illness outbreak, food recall, or other situation
requiring expedited FDA food, dietary supplement, cosmetics, or animal
food or feed communications. So that FDA may better protect the public
health, the Agency needs quick turnaround information provided by this
collection of information to help ensure its messaging has reached the
target audience, has been effective, and, if needed, to update its
communications during these events.
Respondents to this collection of information include a wide range
of consumers and other FDA stakeholders such as producers and
manufacturers of FDA-regulated food and cosmetic products, dietary
supplements, and animal food and feed. Participation will be voluntary.
In the Federal Register of April 18, 2022 (87 FR 22906), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although three comments were received, they
were not responsive to the four collection of information topics
solicited.
We estimate the burden of this collection of information as
follows:
[[Page 51996]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Survey type Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Indepth Interviews, Cognitive Interviews 45 1 45 0.083 (5 minutes)......................... 4
Screener.
Indepth Interviews, Cognitive Interviews.... 9 1 9 1......................................... 9
Indepth Interviews Screener................. 900 1 900 0.083 (5 minutes)......................... 75
Indepth Interviews.......................... 180 1 180 1......................................... 180
Survey Cognitive Interviews Screener........ 45 1 45 0.083 (5 minutes)......................... 4
Survey Cognitive Interviews................. 9 1 9 1......................................... 9
Pretest Survey Screener..................... 750 1 750 0.083 (5 minutes)......................... 62
Pretest Survey.............................. 150 1 150 0.25 (15 minutes)......................... 38
Self-Administered Surveys--Study Screener... 75,000 1 75,000 0.083 (5 minutes)......................... 6,225
Self-Administered Surveys................... 15,000 1 15,000 0.25 (15 minutes)......................... 3,750
Focus Group/Small Group, Cognitive Groups 180 1 180 0.083 (5 minutes)......................... 15
Screener.
Focus Group/Small Group, Cognitive Groups... 60 1 60 1.5 (90 minutes).......................... 90
Focus Group/Small Group Participant 720 1 720 0.083 (5 minutes)......................... 60
Screening.
Focus Group/Small Group Discussion.......... 240 1 240 1.5 (90 minutes).......................... 360
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 10,881
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: August 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18265 Filed 8-23-22; 8:45 am]
BILLING CODE 4164-01-P
